Kornimate/medical-research-clean huggingface dataset:
a study of cm310 in patients with chronic rhinosinusitis with nasal polyposis （crowns-2）

Conditions: Chronic Rhinosinusitis With Nasal Polyposis

Summary: this is a multi-center, randomized, double blind, placebo-controlled phase iii study to evaluate the efficacy and safety of cm310, and to observe the life quality of subjects, the pharmacokinetics, pharmacodynamics and immumogenicity of cm310 in patients with chronic rhinosinusitis with nasal polyposis (crswnp).

the study consists of a screening period (up to 4 weeks), treatment period (24 weeks for double-blind treatment period and 28 weeks for open-label maintenance treatment) and safety follow-up period (8 weeks). 180 patients who meet eligibility criteria will be randomized 1:1 to receive either cm310 300 mg or matched placebo subcutaneously every two weeks (q2w) for a total of 12 times at the double-blind treatment period and 14 times at the open-label treatment period. all patients will receive mfns on a daily basis as a background treatment throughout the study. central reading will be implemented to nasal endoscopic nasal polyp score (nps) , ct scans to lund-mackay score and volume of the involved area of nasosinusitis on 3d-construction images, and nasal polyp biopsy tissue analysis to eosinophil counts \& percentage.

Eligibility criteria:
inclusion criteria: * with chronic rhinosinusitis with nasal polyposis (crswnp). * nasal polyp score (nps) of ≥5 with a minimum score of 2 in each nasal cavity. * ncs score of 2 or 3 at screening period, and at least 2 at baseline. * contraception. exclusion criteria: * not enough washingout period for previous therapy, e.g., less than 10 weeks or 5 half-lives (whichever is longer) for il-4rα antagonists, less than 8 weeks or 5 half-lives for biologic therapy/systemic immunosuppressant, less than 6 months for sinus surgery (including polypectomy). * participated and any studies of cm310. * with malignant or benign tumor of nasal cavity. * vaccination with live attenuated vaccine within 12 weeks before randomization or during the planned study period.
manicaland prep uptake through interactive counselling trial

Conditions: Improving Perceptions of HIV Risk; Improving Uptake of Pre-exposure Prophylaxis for HIV

Summary: primary objective: the purpose of this trial is to evaluate the impact of an interactive tablet based counselling session correcting risk perception and addressing ambiguity around availability, usability and effectiveness of prep on prep uptake within 6 months in adolescent girls and young women (agyw) aged 18-24 years. hypothesis: correcting misperceptions of risks of hiv infection and off-setting ambiguity effects about the availability, usability and efficacy of prep, through localized, interactive, tablet-based counselling, will increase uptake of prep in hiv-negative agyw. study outcomes: the primary outcomes for the study will be risk perception measured in a follow-up survey at 6 months and proportion of women taking up prep within 6 months measured with biomarkers of plasma antiretroviral (arv) drug presence.

with 6 clusters per arm, mean cluster size of 48 individuals, with co-efficient of variation in outcomes between 0.15 to 0.55, the trial will have 80% power to detect difference of 5 - 9 percentage points when baseline prep uptake is assumed to be 1%. primary analysis: a two-stage intention-to-treat (itt) analysis of cluster level summaries will be used. the parameter of interest is the adjusted risk difference in primary and secondary outcomes. in the first stage, logistic regression will be used to adjust for confounding variables at the individual level. the model will be fitted using data from both trial arms. the regression model will include terms for the covariates of interest and pair but not trial arm. adjustment variables will include age group (\<20, 20-24), highest level of education completed, marital status and baseline measures of outcomes. in the second stage, a formal statistical comparison for differences in observed versus expected uptake by arm will be conducted using a two-sided paired significance test with α=0.05. secondary analysis: in secondary analysis, the complier average causal effect (cace) will be estimated using an instrumental variables approach. the parameter of interest is the adjusted risk difference in primary and secondary outcomes. heterogeneity by age and baseline levels of risk and time preferences will also be estimated.

Eligibility criteria:
inclusion criteria: * women * age 18-24 years exclusion criteria: * participants testing hiv-positive at baseline * self-reporting taking prep at baseline

Keywords: pre-exposure prophylaxis (prep) for hiv risk perception hiv
associating liver partition with portal vein ligation for staged hepatectomy (alpps) or portal vein occlusion in treating patients with liver cancer

Conditions: Carcinoma, Hepatocellular

Summary: this randomized phase ii trial compares how well associating liver partition with portal vein ligation for staged hepatectomy (alpps) or portal vein occlusion (pvo) works in treating patients with liver cancer. both treatments are types of 2-stage hepatectomies for removing liver cancer. alpps may be more effective than pvo in patients whose disease would traditionally be considered inoperable.


Eligibility criteria:
inclusion criteria: * patient may have primary or secondary hepatic malignancies with a flr/tlv \ 50 mmol/l, patient may be enrolled into the trial if flr/tlv is \< 40% or flr/bw ratio \< 0.8. * patient must have extensive liver tumors that would require portal vein embolization or a two-stage hepatectomy and portal vein embolization or ligation by the judgment of surgeons in the tumor board. * patient may have extrahepatic disease as long as it may be addressed after liver surgery and there is a tumor board decision to proceed with liver resection (mostly applicable to crc metastases). * patient may have received previous chemotherapy. * in cases of cholestasis, preoperative drainage procedures (ptc or ercp) are left up to judgement of physicians. * patient must be ≥ 18 years of age. the patient population over 65 years old needs to be carefully included based on comorbidities. * patient may have undergone previous liver resection. * patient's location must be such that proper staging and follow-up may be performed. * patient's case must be presented at the multidisciplinary meeting attended by hepatobiliary surgeons, oncologists, hepatologists, and radiologists, or must be approved directly by dr. strasberg or dr. chapman. * patient must be able to understand and willing to sign a written informed consent document. exclusion criteria: * patient must not have any significant concomitant diseases rendering him/her unsuitable for major liver surgery by the judgment of the physicians involved, especially if the patient is \> 65 years old. * patient must not have enrolled into a clinical trial within 4 weeks of study entry. * patient must not have peritoneal carcinomatosis or other extensive extrahepatic disease. * patient must not have advanced stages of carcinoma of the gallbladder (t3/t4) * patient must not have issues such as drug and/or alcohol abuse. * patient must not need major extrahepatic surgery (e.g. pancreas resection, gastric resection, rectal surgery) within 3 months of study entry. * patient must not be a candidate for liver transplantation in case of hcc. * patient must not be pregnant or breastfeeding. if a female of childbearing potential, patient must have a negative pregnancy test within 14 days of enrollment. inclusion of women and minorities -both men and women and members of all races and ethnic groups are eligible for this trial.
comparing intravenous and intramuscular magnesium sulphate for preventing seizure recurrence in women with eclampsia

Conditions: Eclampsia; Seizures; Pregnancy

Summary: the goal of this clinical study is to learn whether the way we give magnesium sulphate-into a vein (intravenous, iv) versus into a muscle (intramuscular, im)-affects how often women with eclampsia have repeat seizures. the main question it aims to answer is: 1. do women who receive iv magnesium sulphate have fewer recurrent seizures than those who receive im magnesium sulphate? researchers will compare two groups of women with eclampsia: one group will receive a bolus and a continuous iv infusion of magnesium sulphate, and the other will receive a combined iv-plus-im dosing regimen. participants will: 1. be women aged 18-45 years diagnosed with eclampsia in the labour room. 2. have their basic health information (age, gestation, parity, body mass index) recorded 3. be randomly assigned (by sealed envelope) to receive either the iv regimen (4 g loading dose then 1 g/hour infusion) or the im regimen (10 g loading dose with 4 g iv plus 6 g im, then 2.5 g im every 4 hours). 4. continue treatment for 24 hours after their last seizure or delivery, whichever is later. 5. be monitored in hospital for seizure recurrence. 6. have any repeat seizure treated immediately with an extra iv dose of magnesium sulphate.


Eligibility criteria:
inclusion criteria: * admitted in labor room due to eclampsia (new onset of grand mal seizure activity and/or unexplained coma during pregnancy) exclusion criteria: * patients with intracranial bleeding (on ct-scan) * already received mgso4, phenytoin and diazepam before attending the hospital

Keywords: magnesium sulphate eclampsia seizures intramuscular intravenous
guanfacine for the treatment of hyperactivity in pervasive developmental disorder

Conditions: Pervasive Development Disorders

Summary: the purpose of this study is to determine whether guanfacine (trade name intuniv) by itself or in combination with methylphenidate (also known as ritalin) is helpful for treating hyperactivity in children and adolescents with a pervasive developmental disorders (pdds).

pervasive developmental disorders (pdds) are a group of conditions that includes autistic disorder, asperger's disorder and so called pervasive developmental disorder - not otherwise specified. children with pdd show delays in speech and language and reduced social interaction. some children with pdd have also have problems with overactivity, impulsiveness and distractability. these behaviors are seen in children with attention deficit hyperactivity disorder (adhd). extended release guanfacine (intuniv) is fda-approved for the treatment of children with adhd. the purpose of this study is to evaluate whether intuniv is an effective treatment for adhd symptoms in children with pdd. this study has four parts: an 8-week double-blind trial, an 8-week blinded extension phase (for positive responders only), an 8-week open-label trial, and a 4-week add-on study. following confirmation of eligibility, participants will be randomly assigned to receive either guanfacine or placebo in the 8-week double-blind trial. children who show improvement after 8 weeks of treatment will continue on their assigned treatment for an additional 8 weeks (blinded extension phase). children who show partial improvement with guanfacine will be offered 4 weeks of treatment with guanfacine plus methylphenidate (add-on study). children who show no improvement on placebo will be offered 8 weeks of treatment with guanfacine (open-label trial). children who show no improvement on guanfacine will exit the study. side effects and treatment response will be assessed at regularly scheduled visits. the study protocol was formally revised with the yale university irb in may 2013 to address an early close to enrollment due to a reduction in funding. the original anticipated enrollment numbers of 112 subjects was reduced to 60 subjects. the study statistician was consulted prior to enrollment closure to address any issues related to statistical power and the adjustments made to the final statiscal analysis plan.

Eligibility criteria:
inclusion criteria: * diagnosis of pdd (pdd-nos, asperger's disorder, autistic disorder) * hyperactivity * between ages 5 years 0 months and 13 years 11 months. * weight \>/= 15 kg (33 lb) * a mental age of at least 18 months exclusion criteria: * prior failed treatment with an adequate trial of guanfacine in the last 2 years * concurrent treatment with another psychoactive medication

Keywords: pervasive developmental disorders pdd pdd-nos autistic disorder autism asperger's disorder hyperactivity attention deficit hyperactivity disorder adhd medication drug guanfacine intuniv placebo methylphenidate
diabetes remission after rygbp and rygbp with fundus resection

Conditions: Type 2 Diabetes; Morbid Obesity; Bariatric Surgery

Summary: the goal of this randomized clinical trial is to evaluate glycemic control in patients with morbid obesity and type 2 diabetes after roux-en-y gastric bypass (rygbp) and rygbp with fundus resection. the main questions to answer are: * rate of diabetes remission and the role of the gastrointestinal hormones * whether fundus resection leads to improved glycemic control patients will randomly undergo typical rygbp or rygbp with fundus resection. gastrointestinal hormones profile \[ghrelin, glucagon-like peptide-1 (glp-1), peptide yy (pyy), glucagon\], glucose levels and insulin response will be measured preoperatively, at 6 months and at 12 months, during 120-min ogtt.


Eligibility criteria:
inclusion criteria: * morbid obesity (βμι ≥ 40) * type ii diabetes mellitus (t2dm) * duration of t2dm shorter than 8 years exclusion criteria: * pregnancy * type 1 diabetes * previous gastrointestinal surgeries * alcohol consumption * depression * no compliance

Keywords: gastric fundus gastrointestinal hormones
learning curve and optimization of robotic gastrectomy

Conditions: Gastric Cancer

Summary: we explore the learning curve and the impact of technique optimization on surgical outcomes and the first to construct a referenceable learning phase for performing robotic gastric cancer surgery.


Eligibility criteria:
inclusion criteria: * case inclusion criteria: (1) patients with pathologically confirmed gastric adenocarcinoma; (2) no distant metastases; and (3) r0 resection was performed. exclusion criteria: * case exclusion criteria: (1) the presence of distant metastases was found ; (2) preoperative neoadjuvant chemotherapy was administered; and (3) clinical information was incomplete.
fitbit one and text messaging prompts to promote physical activity in overweight/obese adults

Conditions: Health Behavior; Obesity

Summary: previous studies suggest self-regulatory techniques including self-monitoring, and sms text-messaging as an intervention modality, can modify health behaviors including physical activity (pa). the primary purpose of this study was to examine change in objectively measured pa in a randomized controlled pilot trial that tested a wearable sensor/device (fitbit one) for self-monitoring and sms text-messaging prompts to promote pa in overweight/obese adults. in a 2-group design, 67 participants were provided the fitbit one and half were randomized to receive 3 daily sms-based pa prompts. a fitbit one was provided to facilitate self-monitoring with a wearable tracker for instant feedback and website of daily pa summaries. outcome measures were number of steps and minutes of pa by intensity-level using two accelerometers: actigraph gt3x+ (primary) at baseline and 6-week follow-up and fitbit one (secondary) at baseline and weeks 1-6. the main hypothesis was that text messaging plus the fitbit one would show a greater increase in steps and minutes of pa compared to only the fitbit one at 6-week follow-up.


Eligibility criteria:
inclusion criteria: * 18-69 years of age * overweight or obese (otherwise healthy) * does not meet recommended levels of pa (\>150 min/wk of mvpa) * owns a personal mobile phone and able to use sms text-messaging * owns a personal computer, has access to internet, able to operate the fitbit one * fluent in english

Keywords: fitbit one wearable sensor wearable device web-based intervention sms text messages randomized controlled trial physical activity behavioral intervention text message prompts text messaging technology exercise
perfusion index changes in cardiovascular autonom neuropathia type-2 dm whit spinal anesthesia

Conditions: Anesthesia; Adverse Effect

Summary: cardiovascular autonomic neuropathy in diabetic patients, hypertension, sympathovagal imbalance, orthostatic hypotension, painless myocardial infarction, ischemia, left ventricular dysfunction, cardiac sympathetic and parasympathetic innervation disturbances, qt interval prolongation and sudden deaths observed. the purpose of this study is to evaluate the relationship between cardiovascular autonomic neuropathy and perfusion index in spinal anesthesia

cardiovascular autonomic neuropathy in diabetic patients, hypertension, sympathovagal imbalance, orthostatic hypotension, painless myocardial infarction, ischemia, left ventricular dysfunction, cardiac sympathetic and parasympathetic innervation disturbances, qt interval prolongation and sudden deaths observed. the purpose of this study is to evaluate the relationship between cardiovascular autonomic neuropathy and perfusion index in spinal anesthesia

Eligibility criteria:
inclusion criteria: * the patient will be operated with spinal anesthesia * over 18 years * no additional disease and only dm exclusion criteria: * patients with additional disease * patients under 18 years of age * patients contraindicated in spinal anesthesia
transcutaneous electrical stimulation of the vagus nerve

Conditions: Cognitive Dysfunction

Summary: this study evaluate the cognitive functions of patient after hip or kneel replacement.half of the patient will receive transcutaneous vagus nerve electrical stimulation during the surgery while the other half will get placebo therapy


Eligibility criteria:
inclusion criteria: * over 65 years old * ability to communication * hip or kneel replacement * willing to participate in the study * asa i-ii exclusion criteria: * with cerebral disorders or disease * cognitive impairment before surgery * with mental disease * unable to communication * severe eyes or ears impairment * surgery performed in the past 30 days * bradycardia，ii°avb，iii°avb，severe heart, liver and kidney dysfunction * severe skin disease * refuse to enter the study

Keywords: postoperative cognitive dysfunction hip- and knee arthroplasty transcutaneous vagus nerve stimulation
a study of tocilizumab + dmards in patients with moderate to severe active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this single arm study will assess the effect of tocilizumab + dmards (disease modifying anti-rheumatic drugs)on improvement of anemia and fatigue in patients with moderate to severe active rheumatoid arthritis. eligible patients who have had an inadequate response to dmards will receive tocilizumab 8mg/kg iv every 4 weeks in combination with standard dmards, for 6 months. the anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * rheumatoid arthritis \>=6 months duration; * das28\>=3.2; * inadequate response to prior treatment with a stable dose (\>=8 weeks) of dmard therapy. exclusion criteria: * rheumatic autoimmune disease other than rheumatoid arthritis; * history of or current inflammatory joint disease other than rheumatoid arthritis; * unsuccessful treatment with an anti-tnf agent; * previous/concurrent treatment with any cell-depleting therapies.
study on prevention of sars-cov-2 transmission during a large indoor gathering event

Conditions: Covid19

Summary: the objective is to demonstrate if there is no increase in the risk of sars-cov-2 salivary carriage 7 days after a concert in the group participating in the event compared to a non participating group who stayed at home. the hypothesis is that a systematic screening of sars-cov-2 within the 3 days before the event allows to control the risk of transmission and prevent cluster of transmission during the concert.

before inclusion, the participants will be able to pre-register to the event via a website. they will get an appointment for an inclusion visit at the accor arena (paris bercy, france). during 3 days (from d-3 to d-1), participants with a registration will come to the accor arena to have a rapid sars-cov-2 antigen test (results in 15 min). if the test is positive, the participant will be contacted and managed by the medical team in charge of the national strategy for positives cases. people with a negative test will be included and randomized : * two kits with tube for collecting saliva samples (for d0 and d7) will be given to each participant at this visit * people randomized in the experimental group will receive their concert ticket at a later date. * at day 0, people randomized in the experimental group, will come to the accor arena with their ticket to participate in the concert. at the entrance, they should give their d0 saliva sampling kit. the people randomized in the control group will stay at home and will send their d0 saliva sample by post mail. * at day 7 (±1 day) all the participants must return their d7 saliva sampling kit via post mail

Eligibility criteria:
inclusion criteria: * aged between 18 and 45 years old * lack of symptoms or no contact with people with covid-19 in the last two weeks * negative antigenic test to covid-19 in the 3 days before the experiment * people who declared to have no risk factor to severe form of covid-19 * people who declared not to live in the same place as someone with these risk factors * people residing in ile-de-france area exclusion criteria: * positive test to sars-cov-2 within 3 days before the concert * people with clinical signs suggesting infectious respiratory disease * people with severe covid-19 risk factor * people living with someone having severe covid-19 risk factor * not affiliated to social security * people who cannot remain standing for the time of the experimentation (about 5 hours) * person under tutorship or curatorship * pregnant women or not having effective contraception method * breastfeeding women

Keywords: sars-cov-2 covid-19 screening concert closed area standing configuration